Post-menopausal women often suffer from a variety of problems associated with a marked reduction in endogenous estrogen production (from 120 pg/ml to around 18 pg/ml). When estrogen levels are low or absent, vascularity of the vagina is reduced and vaginal epithelium is thinned. The decrease in vascularity and vaginal epithelium results in less transudation and vaginal moisture. This may lead to vaginal atrophy, vaginal dryness, incontinence, etc. A decline in estrogen levels may also stem from other factors, such as oral contraceptive use, taking certain medications such as antihistamines, decongestants or antidepressants, intensive exercising, stress, cigarette smoking, frequent douching, and undergoing radiation or chemotherapy treatments. Regardless, estrogen is commonly administered orally, parenterally (e.g., by injection), or topically to increase mucous production and to provide vasodilatory effects. Unfortunately, estrogen-based therapies often result in an increase in moisture, which enhances the likelihood of yeast infection. Yeast infections are common mucus infections that include candida vaginitis, diaper dermatitis (or diaper rash), and oral infections. Candida is an opportunistic pathogen that colonizes to cause for infections. Candida albicans, for example, is present in most humans as a harmless commensal organism. Problems arise, however, when a person experiences a loss of normal bacterial flora. Although several antifungal agents are known to inhibit Candida, such as imidazole-based analogues, multiple therapies are nevertheless needed to treat both atrophic and yeast vaginitis. In addition, many antifungal agents have serious side effects.
As such, a need currently exists for a multi-functional mucosal formulation that is capable of delivering a pharmaceutical agent (e.g., estrogen) and also inhibiting the growth of microorganisms.